NCT02068768终止不适用
A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation
LDR Spine USA4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Fusion Rate
研究概览
简要总结
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
- •Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
- •Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
- •The placement of the Avenue L device must be a primary surgery
- •Subject must be willing to sign the consent form and be able to return for all follow up visits.
排除标准
- •Subject must not have had prior surgery at the operative level(s)
- •Subject is known to have substance or alcohol addictions
- •Subject has lateral curvature of the spine (scoliosis, all types)
- •Subject is a prisoner
- •Subject is pregnant
- •Subject has an active infection or sepsis at the time of surgery
- •Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations
结局指标
主要结局
Fusion Rate
时间窗: 12 months after device implantation
Number of participants with fused disc space as measured radiographically
次要结局
- Mean Oswestry Disability Index (ODI)(preop, 3 mo, 6 mo, 12 mo post op)
- Visual Analog Scale (VAS) of Back Pain(preop, 3 mo, 6 mo, 12 mo)
研究者
研究点 (4)
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